CITY HOSPITALS SUNDERLAND NHS FOUNDATION TRUST CLINICAL GOVERNANCE POLICY by lauraarden

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									       CITY HOSPITALS SUNDERLAND NHS FOUNDATION TRUST

                            CLINICAL GOVERNANCE

      POLICY FOR THE INTRODUCTION OF NEW INTERVENTIONAL
                         PROCEDURES

                                 NOVEMBER 2005


BACKGROUND

HSC2003/011 summarises the procedure that is to be followed for clinicians
that wish to introduce new interventional procedures, which they have not
used before or only used outside the NHS. This policy therefore summarises
the Trust’s response to this health circular.

PROCEDURE

An interventional procedure is one used for diagnosis or treatment that
involves incision, puncture, entry into a body cavity, electromagnetic, thermal
or acoustic energy. An interventional procedure should be considered new if
a clinician, no longer in a training post, is using it for the first time in his or her
NHS clinical practice. In addition, if clinicians have not undertaken an
interventional procedure for 5 years and wishes to start practicing this again,
then they will require updating of their skills. The recommendations of this
procedure will then apply.

He/she must seek the approval of the Trust’s Clinical Governance Steering
Committee before introducing the procedure. A proforma must be submitted,
in full, to the Clinical Governance Steering Group (see appendix 1).

As part of the submission the clinician will need to:

•   Summarise the training that they have received. If there is expertise within
    the hospital then training can occur in-house.

•   Provide evidence that any externally set standards of training have been
    achieved

•   Provide documentation, including appropriate assessments/sign-off of
    competence

•   Confirm that all patients offered the procedure are made aware of the
    special status of the procedure and lack of experience of its use. This
    should be done as part of the consent process and should be clearly
    recorded.
•   A statement should also be included to confirm that the interventional
    procedure is already listed on the NICE website. If this is not the case
    then this should be clearly stated.

•   Information on any prospective audit to support the introduction of this
    procedure should also be included

Following review by the appropriate Clinical Governance Steering Committee
the clinician will be informed in writing of the outcome of the committee’s
decision.

EXCEPTIONS TO THIS PROCEDURE

Emergency situations

It is recognised that in rare circumstances where no other treatment option
exists there may be a need to use a procedure in a clinical emergency so as
not to place the patient at serious risk. If a clinician has performed a new
interventional procedure in such circumstances, he/she must inform the Trust
Lead for Clinical Governance within 72 hours. The Clinical Governance
Steering Group will then consider approval of the interventional procedure for
future use.

Research

Procedures that are being used only within a protocol approved by a
Research Ethics Committee are excluded from this procedure.

REFERENCES

HSC 2003/011 The Interventional Procedures Programme. Department of
Health (November 2003)




Les Boobis
Medical Director




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                                                                                             Appendix 1




                    INTRODUCING NEW INTERVENTIONAL PROCEDURES

                              INTENTION TO PRACTICE PROFORMA

HSC 2003/011 outlines new formal arrangements for clinicians planning to
undertake new interventional procedures*. Approval needs to come from the
Trust Clinical Governance Steering Group before doing so. This proposal form
should be completed in full to assist the Steering Group to make that decision.

    •    Interventional procedure is one used for diagnosis or treatment that
         involves incision, puncture, entry into a body cavity, electromagnetic,
         thermal or acoustic energy.

Name of person wishing to practice                              Grade


Name of intervention (NICE reference no. if applicable)         Specialty


Description of intervention (including type of patient and other clinical scenarios)




Details of training undertaken & competencies achieved




Likely number of patients affected (approx)             Start date



Criteria                                                                               Y/N
Training received in the procedure
Evidence of externally set standards of training have been achieved
Appropriate assessment of competence sign-off
Confirmation that patients are made aware of the special status of the procedure
(done as part of consent process)
Confirmation that the interventional procedure is listed on the NICE website
Audit information to support the introduction of the procedure (or specific plans to
audit)
Signature of person                                Approval by Clinical Director


Approval by CGSG                            Y/N                            Date:
Review date:
Person responsible for developing the proforma :



Interventional procedures/proforma2005




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